Process Engineer – Sterile Compounding

📋 Description • Hims & Hers, a leading health and wellness platform committed to making healthcare accessible, affordable, and personalized, is seeking a highly skilled and motivated Process Engineer to join our dynamic team in Gilbert, Arizona. This critical role will be instrumental in supporting our sterile injectable compounding operations across both 503A and 503B facilities, ensuring the highest standards of quality, safety, and efficiency in the production of hazardous (HD) and non-hazardous (NHD) drug products. • As a Process Engineer, you will be at the forefront of designing, optimizing, and validating aseptic processes that are fundamental to our sterile injectable manufacturing. Your expertise will be crucial in areas such as laminar airflow hoods, open Restricted Access Barrier Systems (oRABS), sophisticated fluid path design, rigorous filter integrity testing, and the strategic selection and management of both single-use and reusable components. This role demands a hands-on approach and a deep understanding of the intricate requirements of sterile compounding environments. • **Process Design & Optimization:** You will be responsible for the end-to-end design and continuous optimization of sterile injectable compounding processes. This includes developing robust aseptic techniques, meticulously designing fluid paths, and implementing effective containment strategies for both HD and NHD products. You will play a key role in selecting and integrating essential equipment, such as laminar flow hoods, oRABS, peristaltic pumps, and advanced filtration units, always considering the optimal balance between single-use and reusable components to enhance efficiency and minimize waste. • **Risk Management & Lean Methodologies:** A significant part of your role will involve conducting comprehensive risk assessments, including Failure Mode and Effects Analysis (FMEA), to proactively identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). You will leverage Lean and Six Sigma methodologies to streamline batch production, reduce waste, and enhance overall operational efficiency. This includes performing detailed time studies, process mapping, and capacity analyses to ensure our compounding and fill/finish workflows are as efficient and effective as possible. • **Aseptic Practices & Cleanroom Support:** You will actively support the development and execution of aseptic techniques for both terminally sterilized and aseptically filled products. Collaboration with cleanroom personnel is paramount, ensuring adherence to proper gowning procedures, efficient material and personnel flow, and the strict maintenance of HEPA-filtered environment controls. You will work closely with the Quality Assurance (QA) team to guarantee unwavering compliance with critical regulatory standards, including USP <797>, USP <800>, NIOSH guidelines, and current Good Manufacturing Practices (cGMP) for the safe handling and containment of hazardous drugs. • **Equipment & Facility Integration:** You will be involved in specifying, installing, and qualifying a range of critical compounding equipment, including Biosafety Cabinets (BSCs), Laminar Airflow Workstations (LAFW), autoclaves, filtration units, and isolators. Partnering with validation teams, you will contribute to the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of sterile compounding equipment and associated critical systems. Furthermore, you will assist in vital facility-related studies, such as airflow visualization, pressure differential control, and HVAC balancing for sterile suites, ensuring the integrity of the controlled environment. • **Process Validation & Documentation:** A core responsibility will be the development of Process Validation (PV) protocols for both new and existing products, followed by active participation in their execution and data analysis. You will be responsible for authoring and maintaining essential documentation, including Standard Operating Procedures (SOPs), batch records, deviation reports, and process change documentation, all in strict accordance with internal procedures and regulatory expectations. Your support will also extend to cleaning validation, media fill simulations, and environmental monitoring investigations when deviations arise. You will also participate in IQOQ execution activities onsite and collaborate with QA teams to ensure all compliance requirements are met and signed off. • **Regulatory Compliance & Technology Transfer:** Ensuring all operational activities strictly adhere to USP <797>, USP <800>, FDA cGMP, and relevant ISO standards (e.g., ISO 14644) is non-negotiable. You will be instrumental in preparing and maintaining comprehensive documentation, including risk assessments, deviation reports, Corrective and Preventive Actions (CAPAs), and change control documentation. Leading technology transfer efforts for new injectable products into our manufacturing environment will be a key aspect of this role, requiring close collaboration with QA, validation, pharmacy, engineering, and manufacturing teams to ensure seamless implementation and operational readiness. • **Continuous Improvement & Audit Readiness:** You will continuously analyze process data to monitor trends, identify opportunities, and drive ongoing improvements in compounding performance and overall efficiency. Proactive troubleshooting of equipment malfunctions, process deviations, and facility issues that impact sterile production will be essential. Ensuring that all documentation and systems are consistently audit-ready for internal reviews and external inspections by regulatory bodies such as the FDA or State Boards of Pharmacy is a critical expectation. You will actively participate in regulatory inspections, providing expert technical support related to process design and validation. • This role offers a unique opportunity to make a significant impact on the quality and efficiency of sterile injectable manufacturing within a rapidly growing, mission-driven company. You will be a key contributor to Hims & Hers' commitment to providing high-quality, personalized healthcare solutions.